Prescription drug · ANDA
amantadine hydrochloride NDC 68382-512
Amantadine hydrochloride 100 mg/1 · Capsule · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-512-01 | 68382051201 | 100 CAPSULE in 1 BOTTLE (68382-512-01)Marketed from Aug 4, 2016 | |
| 68382-512-05 | 68382051205 | 500 CAPSULE in 1 BOTTLE (68382-512-05)Marketed from Aug 4, 2016 | |
| 68382-512-06 | 68382051206 | 30 CAPSULE in 1 BOTTLE (68382-512-06)Marketed from Aug 4, 2016 | |
| 68382-512-77 | 68382051277 | 10 BLISTER PACK in 1 CARTON (68382-512-77) / 10 CAPSULE in 1 BLISTER PACK (68382-512-30)Marketed from Aug 4, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- amantadine hydrochloride
- Generic name (nonproprietary)
- amantadine hydrochloride
- Active ingredients
- Amantadine hydrochloride — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208278
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 68382-512_6e270f1c-83bd-4c12-a810-69f7c797fd61SPL ID 6e270f1c-83bd-4c12-a810-69f7c797fd61SPL set ID 609dc911-1e9d-4ebd-b64b-f44054e5582eRxCUI 849389UNII M6Q1EO9TD0
- Pharmacologic class
- Influenza A M2 Protein Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468382051201followed by a unit qualifier and the quantityPackage 68382-0512-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protecte…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208278
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1508 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | AvKARE | 73190-094 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-835 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0469 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-702 |